Kymera Therapeutics Inc
For the period ended Sep 30, 2024. Filed Oct 31, 2024.
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Sep 30, 2024 · Filed Oct 31, 2024
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Notes to Unaudited Condensed Consolidated Financial Statements
NOTES TO CONDENSED CONSOLID ATED FINANCIAL STATEMENTS
- Organization and Nature of Business
Kymera Therapeutics, Inc., together with its subsidiary Kymera Securities Corporation, is referred to on a consolidated basis as the “Company”. The Company is a biopharmaceutical company focused on discovering and developing small molecule therapeutics that selectively degrade disease-causing proteins by harnessing the body’s own natural cellular process, a method known as targeted protein degradation. The Company has devoted its efforts principally to research and development since formation. The Company has not yet completed product development, filed for or obtained regulatory approvals for any products, nor verified the market acceptance and demand for such products. As a result, the Company is subject to a number of risks common to emerging companies in the biotech industry. Principal among these risks are the uncertainties of the product discovery and development process, dependence on key individuals, development of the same or similar technological innovations by the Company’s competitors, protection of proprietary technology, compliance with government regulations and approval requirements, the Company’s ability to access capital and uncertainty of market acceptance of products.
The Company has historical net losses and anticipates that it will continue to incur losses for the foreseeable future and had an accumulated deficit of$683.9 million as of September 30, 2024. The Company has funded these losses principally through issuance of preferred stock, convertible notes, common stock, including its initial public offering and concurrent private placement completed in August 2020 (“IPO”), follow-on offering and concurrent private placement completed in July 2021 (“2021 Follow-on”) offering, August 2022 Private Investment in Public Equity (“PIPE”) offering, follow-on offerings completed in January 2024 ("2024 Follow-on") and August 2024 Offering ("August 2024 Follow-on"), sales under our Sales Agreement with Cowen, and from cash proceeds received in connection with the Company’s collaboration agreements with Vertex Pharmaceuticals Incorporated (“Vertex”) and Genzyme Corporation (“Sanofi”) (see Note 5). The Company expects to continue to incur operating losses and negative operating cash flows until such time as it generates a level of revenue that is sufficient to support its cost structure.
As of September 30, 2024, the Company had cash, cash equivalents and marketable securities of$911.0 million. The Company believes these cash, cash equivalents and marketable securities will be sufficient to fund its operations and capital expenditure requirements through at least twelve months from the issuance of these condensed consolidated financial statements.
The Company expects to finance the future research and development costs of its product portfolio with its existing cash, cash equivalents and marketable securities, or through strategic financing opportunities that could include, but are not limited to future offerings of its equity, collaboration agreements, or the incurrence of debt. However, there is no guarantee that any of these strategic or financing opportunities will be executed or realized on favorable terms, if at all, and some could be dilutive to existing stockholders. If the Company fails to obtain additional future capital, it may be unable to complete its planned preclinical studies and clinical trials.
Private Investment in Public Equity “PIPE” offering
On August 18, 2022, the Company and certain accredited investors entered into a securities purchase agreement pursuant to which the Company agreed to sell and issue to such investors in a private placement (i) an aggregate of 2,769,228 shares of the Company’s common stock at a purchase price of $26.00 per share, and (ii)3,000,000 pre-funded warrants to purchase common stock, at a purchase price of $25.9999 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.0001 per share of common stock. The offering closed on August 22, 2022, resulting in net proceeds of $149.8 million after offering expenses.
2024 Follow-on Public Offerings
On January 9, 2024, the Company completed a follow-on offering of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. The Company issued and sold 3,884,158 shares of common stock, including full exercise of the underwriters’ over-allotment option to purchase an additional 1,633,663 shares, at a public offering price of $25.25 per share. Additionally, in lieu of common stock to certain investors, the Company issued and sold pre-funded warrants to purchase 8,640,594 shares of its common stock at a public offering price of $25.2499 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant. The aggregate gross proceeds before deducting underwriting discounts and commissions, and other estimated offering expenses payable by the Company were approximately $316.2 million.
On August 21, 2024, the Company completed a follow-on offering of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. The Company issued and sold 2,830,533 shares of common stock, including full exercise of the underwriters’ over-allotment option to purchase an additional 828,220 shares, at a public offering price of $40.75 per share. Additionally, in lieu of common stock to certain investors, the Company issued and sold pre-funded warrants to purchase 3,519,159 shares of its common stock at a public offering price of $40.7499 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant. The aggregate gross proceeds before deducting underwriting discounts and commissions, and other estimated offering expenses payable by the Company were approximately $258.7 million.
Pre-funded warrants
In connection with certain offerings mentioned above the Company has issued pre-funded warrants to purchase common stock in lieu of common stock. As the pre-funded warrants are indexed to the Company’s common stock (and otherwise meet the requirements to be classified in equity), the Company recorded the consideration received from the issuance of the pre-funded warrants as additional paid-in capital on the Company’s consolidated balance sheets. The pre-funded warrants are exercisable at any time. The holders of Pre-Funded Warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the holder,9.99%) of the number of shares of the Common Stock outstanding immediately after giving effect to such exercise. The holders of Pre-Funded Warrants may increase or decrease such percentages not in excess of 19.99% by providing at least 61 days’ prior notice to the Company.
During the three and nine months ended September 30, 2024, no pre-funded warrants were exercised. As of September 30, 2024, there were 15,159,753 pre-funded warrants outstanding.
- Summary of Significant Accounting Policies
The accompanying condensed consolidated financial statements reflect the application of certain significant accounting policies as described in this note, and elsewhere in the accompanying condensed consolidated financial statements and notes.
Principles of Consolidation
The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary Kymera Securities Corporation. All intercompany transactions and balances have been eliminated in consolidation.
Basis of Presentation
The unaudited interim condensed consolidated financial statements of the Company included herein have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) as found in the Accounting Standards Codification (“ASC”), Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”) and the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, filed with the SEC on February 22, 2024.
The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2023, and, in the opinion of management, reflect all adjustments necessary, all of which were normal and recurring, for the fair statement of the Company’s financial position as of September 30, 2024, and the results of operations, equity, and cash flows for the nine months ended September 30, 2024 and 2023. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results for the year ended December 31, 2024 or for any future period.
Significant Accounting Policies
The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 2024 are consistent with those discussed in Note 2 to the consolidated financial statements in the 2023 Annual Report on Form 10-K.
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update requires disclosure of incremental segment information on an annual and interim basis. This update is effective for annual periods beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024. Early adoption is permitted. This guidance should be applied retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact on its financial statements of adopting this guidance.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This update requires that public entities on an annual basis, (1) in the rate reconciliation, disclose specific categories and provide additional information for reconciling items that meet a quantitative threshold; (2) about income taxes paid, disclose the amount of income taxes paid (net of refunds received) disaggregated by federal, state, and foreign taxes and by individual jurisdiction in which income taxes paid (net of refunds received) is equal to or greater than 5 percent of total income taxes paid (net of refunds received); and (3) disclose income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign and income tax expense (or benefit) disaggregated by federal, state, and foreign. This update is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. This guidance should be applied on a prospective basis. Retrospective application is permitted. The Company is currently evaluating the impact on its financial statements of adopting this guidance.
- Fair Value Measurements
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicates the level of the fair value hierarchy utilized to determine such fair values as of September 30, 2024 and December 31, 2023 (in thousands):
| Fair Value Measurements atSeptember 30, 2024: | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| Assets: | ||||
| Cash equivalents | ||||
| Money market fund | $21,032 | $— | $— | $21,032 |
| US treasuries | 65,362 | — | — | $65,362 |
| US government agencies | — | 4,789 | — | $4,789 |
| Commercial Paper | — | 12,944 | — | $12,944 |
| Marketable securities, current | ||||
| US treasuries | 122,404 | — | — | 122,404 |
| US government agencies | — | 68,369 | — | 68,369 |
| Commercial Paper | — | 28,603 | — | 28,603 |
| Corporate bonds | — | 219,876 | — | 219,876 |
| Marketable securities, non-current | ||||
| US treasuries | 48,760 | — | — | 48,760 |
| US government agencies | — | 117,594 | — | 117,594 |
| Corporate bonds | — | 194,681 | — | 194,681 |
| Restricted cash | 5,783 | — | — | 5,783 |
| Total | $263,341 | $646,856 | $— | $910,197 |
| Fair Value Measurements atDecember 31, 2023: | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| Assets: | ||||
| Cash equivalents | ||||
| Money market fund | $78,010 | $— | $— | $78,010 |
| US treasuries | 27,985 | — | — | 27,985 |
| Commercial Paper | 997 | — | — | 997 |
| Marketable securities, current | ||||
| US treasuries | 23,253 | — | — | 23,253 |
| US government agencies | — | 114,384 | — | 114,384 |
| Corporate bonds | — | 127,278 | — | 127,278 |
| Marketable securities, non-current | ||||
| US treasuries | — | — | — | - |
| US government agencies | — | 28,307 | — | 28,307 |
| Corporate bonds | — | 33,127 | — | 33,127 |
| Restricted cash | 5,811 | — | — | 5,811 |
| Total | $136,056 | $303,096 | $— | $439,152 |
During the nine months ended September 30, 2024 and the year ended December 31, 2023, there wereno transfers in or out of Level 3.
- Marketable Securities
The following tables summarize the available-for-sale debt securities held at September 30, 2024 and December 31, 2023 (in thousands):
| Description | AmortizedCost | UnrealizedGains | UnrealizedLosses | FairValue |
|---|---|---|---|---|
| US treasury securities | $170,704 | $484 | $(24) | $171,164 |
| US government agencies | 186,095 | 212 | (344) | $185,963 |
| Commercial Paper | 28,587 | 17 | (1) | $28,603 |
| Corporate securities | 412,982 | 1,621 | (46) | $414,557 |
| Total | $798,368 | $2,334 | $(415) | $800,287 |
| Description | AmortizedCost | UnrealizedGains | UnrealizedLosses | FairValue |
|---|---|---|---|---|
| US treasury securities | $23,361 | $5 | $(113) | $23,253 |
| US government agencies | 142,948 | 48 | (305) | 142,691 |
| Corporate securities | 160,598 | 113 | (306) | 160,405 |
| Total | $326,907 | $166 | $(724) | $326,349 |
As of September 30, 2024, the Company held 47 securities that had been in an unrealized loss position for less than 12 months with an aggregate fair value of $296.4 million. As of December 31, 2023, the Company held 109 securities that had been in an unrealized loss position for less than 12 months with an aggregate fair value of $229.7 million. As of September 30, 2024, the Company held 17 securities that had been in an unrealized loss position for greater than 12 months with an aggregate fair value of $32.9 million As of December 31, 2023, the Company held 16 securities that had been in an unrealized loss position for greater than 12 months with an aggregate fair value of $36.6 million.
As of September 30, 2024 the Company had 142 securities with a fair value of $439.3 million with a contractual maturity of less than 12 months and 117 securities with a fair value of $361.0 million with a contractual maturity of greater than 12 months. As of December 31, 2023 the Company had 124 securities with a fair value of $264.9 million with a contractual maturity of less than 12 months and 27 securities with a fair value of $61.4 million with a contractual maturity of greater than 12 months.
The Company is required to determine whether a decline in the fair value below the amortized cost basis of available-for-sale securities is due to credit-related factors. At each reporting date, the Company performs an evaluation of impairment to determine if any unrealized losses are the result of credit losses. Impairment is assessed at the individual security level. Factors considered in determining whether a loss resulted from a credit loss or other factors include the Company’s intent and ability to hold the investment until the recovery of its amortized cost basis, the extent to which the fair value is less than the amortized cost basis, the length of time and extent to which fair value has been less than the cost basis, the financial condition of the issuer, any historical failure of the issuer to make scheduled interest or principal payments, any changes to the rating of the security by a rating agency, any adverse legal or regulatory events affecting the issuer or issuer’s industry, and any significant deterioration in economic conditions.
Unrealized losses on available-for-sale securities presented in the previous table have not been recognized in the condensed consolidated statements of operations because the securities are high credit quality, investment grade securities that the Company does not intend to sell and will not be required to sell prior to their anticipated recovery, and the decline in fair value is attributable to factors other than credit losses. Based on its evaluation, the Company determined it doesnot have any credit losses related to its available-for-sale securities as of September 30, 2024 and December 31, 2023.
- Collaborations
Sanofi Agreement
Agreement Terms
On July 7, 2020, the Company entered into a collaboration agreement, or the Sanofi Agreement, with Sanofi, to co-develop drug candidates directed to two biological targets. Under the Sanofi Agreement, the Company granted to Sanofi a worldwide exclusive license to develop, manufacture and commercialize certain lead compounds generated during the collaboration directed against IRAK4, or Collaboration Target 1, and one additional undisclosed target in an undisclosed field of use, or Collaboration Target 2. Such license is exercisable on a collaboration target-by-collaboration target basis only after specified milestones. For compounds directed against IRAK4, the field of use includes diagnosis, treatment, cure, mitigation or prevention of any diseases, disorders or conditions, excluding oncology and immuno-oncology.
Pursuant to the Sanofi Agreement, the Company is responsible for discovery and preclinical research and conducting a Phase 1 clinical trial for at least one degrader directed against IRAK4 plus up to three backup degraders. With respect to both targets, Sanofi is responsible for development, manufacturing, and commercialization of product candidates after a specified development milestone occurs with respect to each collaboration candidate.
In addition, pursuant to the Sanofi Agreement, Sanofi will grant to the Company an exclusive option, or Opt-In Right, exercisable on a collaboration target-by-collaboration target basis that will include the right to (i) to fund 50% of the United States development costs for collaboration products directed against such target in the applicable field of use and (ii) share equally in the net profits and net losses of commercializing collaboration products directed against such target in the applicable field of use in the United States. In addition, if the Company exercises the Opt-In Right, Sanofi will grant to the Company an exclusive option, applicable to each collaboration target, which upon exercise will allow the Company to conduct certain co-promotion activities in the field in the United States.
The Sanofi Agreement, unless earlier terminated, will expire on a product-by-product basis on the date of expiration of all payment obligations under the Sanofi Agreement with respect to such product. The Company or Sanofi may terminate the agreement upon the other party’s material breach or insolvency or for certain patent challenges. In addition, Sanofi may terminate the Sanofi Agreement for convenience or for a material safety event upon advance prior written notice, and the Company may terminate the Sanofi Agreement with respect to any collaboration candidate if, following Sanofi’s assumption of responsibility for the development, commercialization or manufacturing of collaboration candidates with respect to a particular target, Sanofi ceases to exploit any collaboration candidates directed to such target for a specified period.
In consideration for the exclusive licenses granted to Sanofi under the Sanofi Agreement, Sanofi paid to the Company an upfront payment of $150.0 million. The Company will also be reimbursed for certain research activities for a certain backup degrader under the IRAK4 program as well as contract manufacturing costs for the lead KT-474 program, unless certain criteria are not met for an initial IRAK4 degrader. In addition to the upfront payment and the reimbursements, the Company is eligible to receive certain development milestone payments of up to $1.48 billion in the aggregate, of which more than $1.0 billion relates to the IRAK4 program, upon the achievement of certain developmental or regulatory events. The Company will be eligible to receive certain commercial milestone payments up to $700.0 million in the aggregate, of which $400.0 million relates to the IRAK4 program, which are payable upon the achievement of certain net sales thresholds. The Company will be eligible to receive tiered royalties for each program on net sales ranging from the high-single digits to high teens, subject to low-single digits upward adjustments in certain circumstances.
On November 15, 2022, we entered into an Amended and Restated Collaboration and License Agreement with Sanofi, or the Amended Sanofi Agreement, which amended the Original Sanofi Agreement to revise certain research terms and responsibilities set forth under the Original Sanofi Agreement. The Amended Sanofi Agreement also specifies details around the timing and number of Phase 2 trials required under the terms of the collaboration. The Amended Sanofi Agreement became effective on December 5, 2022.
Additionally with respect to Sanofi, on December 2, 2022, Sanofi provided the Company with written notice of its intention to advance the collaboration target 1 candidate, KT-474, into Phase 2 clinical trials. In the fourth quarter of 2023, the Company achieved two milestones of $40.0 million and $15.0 million relating to the dosing of the first patient in the Phase 2 clinical trial for the first and second indications, respectively. Further, in July 2024, the Company announced that Sanofi intends to expand the ongoing Phase 2 trials to more rapidly progress towards pivotal studies with the intention of accelerating overall timelines.
In September 2023, the Company and Sanofi mutually agreed to cease activities related to Collaboration Target 2.
Accounting Treatment
The Company analyzed the discovery and pre-clinical research activities as well as the exclusive license grants under the Sanofi Agreement and concluded that the arrangement was indicative of a vendor-customer relationship and would be accounted for under ASC 606.
The Company identified the following material promises under the arrangement: (1) research services for Collaboration Target 1, (2) research license for Collaboration Target 1, (3) exclusive license for Collaboration Target 1, (4) research services for Collaboration Target 2, (5) research license for Collaboration Target 2, (6) exclusive license for Collaboration Target 2, (7) option to extend the research term, and (8) optional research services during the development period.
The Company determined that Collaboration Targets 1 and 2 are distinct from each other. The research associated with degraders directed to each target is at different stages and the licensed field, should development activities be successful, are different from each other. As such, all promises associated with each target are considered distinct from promises associated with the other target.
The research and development services for each collaboration target were determined not to be distinct from the research license and the exclusive license and have been combined into a single performance obligation for each collaboration target. That is, two performance obligations were identified, the combined research services, research license and exclusive license for Collaboration Target 1 and the combined research services, research license and exclusive license for Collaboration Target 2. The exclusive license for each target is not distinct from the pre-clinical and clinical research and development services under the Sanofi Agreement, primarily due to the highly specialized nature of the research and novel technology involved with developing protein degraders – the pre-clinical activities and studies and first phase 1 clinical trial could not be conducted by another party in the manner required.
The option to extend the research term and optional research services during the development period were evaluated as material rights. The fees associated with each option are at or above the standalone selling price. As such, the underlying options are not performance obligations and fees associated with each option are excluded from the transaction price until the underlying option is exercised.
The Company determined the total transaction price to be $150.0 million, which consists solely of the upfront payment. All milestone payments and option payments are constrained as the achievement of such milestones are contingent upon the success of the underlying research and development activities and are generally outside the control of the Company. The reimbursement of costs for the IRAK4 backup degrader is also treated as constrained variable consideration as the criteria for reimbursement may not always be met, under which circumstances the Company would be responsible for the costs related to the backup degrader. Upon becoming unconstrained, the reimbursement consideration will be added to the transaction price and allocated to Collaboration Target 1.
The Company allocated the upfront payment to each performance obligation based on the relative standalone selling price, as follows:
Collaboration Target 1: $120.0 million
Collaboration Target 2: $30.0 million
The Company determined the allocation of the $150.0 million transaction price between Collaboration Target 1 and Collaboration Target 2 based on the value of the research and development for the programs from projected research and development costs for each collaboration target plus a developer’s profit and the total potential milestones for each collaboration target.
The Company recognizes revenue associated with each performance obligation as the research and development services are provided using an input method, according to costs incurred as related to the research and development activities for each individual program and the costs expected to be incurred in the future to satisfy that individual performance obligation. The transfer of control occurs over this time period and, in management’s judgment, is the best measure of progress towards satisfying each performance obligation. The amounts received that have not yet been recognized as revenue are deferred as a contract liability on the Company’s consolidated balance sheet and will be recognized over the remaining research and development period until the performance obligation is satisfied. Milestone and reimbursement consideration added to the transaction price will be recognized as revenue with a cumulative catch-up upon becoming unconstrained. The performance obligation associated with Collaboration Target 1 has not been fully satisfied as of September 30, 2024. The performance obligation associated with Collaboration Target 2 has been fully satisfied. In the three months ended September 30, 2024, the Company recognized $3.7 million in revenue under the Sanofi Agreement, all of which was associated with Collaboration Target 1. In the nine months ended September 30, 2024, the Company recognized $39.7 million in revenue under the Sanofi Agreement, all of which was associated with Collaboration Target 1. In the three months ended September 30, 2023, the Company recognized $4.7 million in revenue under the Sanofi Agreement, of which $4.0 million was associated with Collaboration Target 1 and $0.7 million was associated with Collaboration Target 2. In thenine months ended September 30, 2023, the Company recognized $22.3 million in revenue under the Sanofi Agreement, of which $19.8 million was associated with Collaboration Target 1 and $2.5 million was associated with Collaboration Target 2. Of the $39.7 million of revenue recognized in the nine months ended September 30, 2024,$35.1 million was recognized from amounts that were recorded in deferred revenue as of December 31, 2023. The aggregate amount of the transaction price allocated to the Company’s unsatisfied performance obligations and recorded in deferred revenue at September 30, 2024 and December 31, 2023 is $20.0 million and $54.7 million, respectively. This decrease was the result of on-going activity under the collaboration agreement as well asa $19.4 million cumulative catch-up to revenue related to the change in expected future costs to satisfy the Company's performance obligation under Collaboration Target 1 that occurred during the nine months ended September, 2024. During the nine months ended September 30, 2024, the Company received $7.5 million in cost reimbursement payments. As of September 30, 2024, the Company recorded a contract asset for unbilled accounts receivable of $1.3 million related to reimbursable research and development costs under the Sanofi Agreement for activities performed during the third quarter of 2024. The Company will recognize the deferred revenue related to the research and development services based on a cost input method, as described, over the remaining research term, which is a maximum of 1 year as of September 30, 2024.
Any additional consideration related to performance-based milestones will be recognized when the risk of probable reversal is resolved, at which point the Company shall adjust the transaction price determined for the agreement accordingly and recognize revenue on a cumulative-catch up basis, reallocating the revised arrangement consideration to the performance obligations. Any consideration related to sales milestone payments and royalties will be recognized when the related milestone events or sales occur and therefore are recognized at the later of when the related sales occur or the relevant performance obligation is satisfied. As part of its evaluation of constraining the milestones, the Company considered numerous factors, including the fact that the achievement of the research and development milestones are contingent upon the results of the underlying research and development activities and are thus outside of the control of the Company. In the fourth quarter of 2023, the Company achieved two development milestones relating to the dosing of the first patient in the KT-474 Phase 2 clinical trials for the first and second indications, respectively. In connection with these milestones the Company unconstrained $55.0 million of consideration in the fourth quarter of 2023. During thethree and nine months ended September 30, 2024, the Company recognized $0.7 million and $9.5 million of revenue from the unconstrained milestones, respectively. As of September 30, 2024, $49.7 million of the $55.0 million of consideration has been recorded as revenue, with the remaining $5.3 million recorded as deferred revenue.
Vertex Agreement
On May 9, 2019 (the “Effective Date”), the Company entered into a collaboration agreement (the “Vertex Agreement”) with Vertex to advance small molecule protein degraders against up to six targets. Under the Vertex Agreement, Vertex had the exclusive option to license the rights to the product candidates developed for the designated targets at which point Vertex would control development and commercialization. Pursuant to the Vertex Agreement, the Company was only responsible for discovery and preclinical research on the targets, and Vertex was responsible for development, manufacturing, and commercialization of the product candidates after it exercises its option to license. The initial research term of the collaboration was four (4) years, extendable for an additional one (1) year period upon mutual agreement by the parties and payment by Vertex of certain per-target fees.
The Company was eligible to receive up to $170.0 million in payments per target, including development, regulatory and commercial milestones as well as option exercise payments. In addition, Vertex was obligated to pay the Company tiered royalties on future net sales on any products that may result from the Vertex Agreement. None of the payments under the Vertex Agreement are refundable. The Company may also perform follow-on research for an optioned target upon Vertex’s request and at Vertex’s expense.
The term of the Vertex Agreement began on the Effective Date and expired upon the completion of the initial research term on May 9, 2023.
Vertex provided the Company with a non-refundable upfront payment of $50.0 million and purchased 3,059,695 shares of the Company’s Series B-1 Convertible Preferred Stock (the “Series B-1 Preferred Stock”) at $6.54 a share, pursuant to a separate, but simultaneously executed Share Purchase Agreement. The shares were purchased at a premium of $5.9 million, which was included in the transaction price and will be recognized as revenue over the period of performance. As a result of this purchase, Vertex was considered a related party. Vertex is no longer considered a related party.
Accounting Treatment
The Company analyzed the joint research activities required under the Vertex Agreement and concluded that the arrangement was indicative of a vendor-customer relationship and would be accounted for under ASC 606.
The Company identified the following material promises under the arrangement: (1) the non-exclusive, royalty-free research license; (2) the research and development services to be performed on up to six targets; and (3) the option to license each of the targets for development, manufacturing, and commercialization efforts. The research and development services were determined not to be distinct from the research and development license and have been combined into a single performance obligation. The Company determined that the option to license the targets in the future was not priced at a discount, and that the option exercise fee for each target is at or above the standalone selling price for research at this stage of development; as such, the options and the underlying licenses are excluded from the performance obligation and the option exercise fees are excluded from the transaction price until the underlying option is exercised.
As part of its evaluation of constraining the research and development milestones, the Company considered numerous factors, including the fact that the achievement of the research and development milestones is contingent upon the results of the underlying research and development activities and is thus outside of the control of the Company.
At the commencement of the arrangement, two units of accounting were identified: the issuance of 3,059,695 shares of the Series B-1 Preferred Stock and the research activities the Company will perform over the Research Term. The Company determined the total transaction price to be $55.9 million, which consists of $5.9 million attributed to the premium from the shares of Series B-1 Preferred Stock sold to Vertex and the $50.0 million upfront payment. To determine the fair value of the Series B-1 Preferred Stock issued to Vertex, the Company performed a valuation of the shares of the Company’s common and preferred stock, which took into consideration recent financings, and the Company’s recent development and future exit strategies, as well as a discount for lack of marketability.
The Company recognizes revenue associated with the performance obligation as the research and development services are provided using an input method, according to the costs incurred as related to the research and development activities on each program and the costs expected to be incurred in the future to satisfy the performance obligation. The transfer of control occurs over this time period and, in management’s judgment, is the best measure of progress towards satisfying the performance obligation. The Vertex collaboration agreement expired upon completion of the initial research term in May of 2023. Accordingly, the Company fully satisfied its performance obligation and recognized all remaining deferred revenue associated with the Vertex collaboration in May 2023. No revenue was recognized during the three and nine months ended September 30, 2024 under the Vertex Agreement. During the three months ended September 30, 2023 the Company recognized no revenue under the Vertex Agreement. During the nine months ended September 30, 2023 the Company recognized $8.4 million in revenue under the Vertex Agreement, all of which was included in deferred revenue as of December 31, 2022. There wereno unsatisfied performance obligations as of September 30, 2024. The aggregate amount of the transaction price allocated to the Company’s unsatisfied performance obligation and recorded in deferred revenue is $0 at both September 30, 2024 and December 31, 2023.
The following table presents the changes in accounts receivable, contract assets and contract liabilities for the nine months ended September 30, 2024 (in thousands):
| Balance at December 31,2023 | Additions | Deductions | Balance at September 30,2024 | |
|---|---|---|---|---|
| Accounts receivable and contract assets: | ||||
| Billed receivables - Sanofi | $15,000 | $7,496 | $(22,496) | $— |
| Unbilled receivables - Sanofi | 3,762 | 5,051 | (7,496) | 1,317 |
| Total accounts receivable and contract assets | $18,762 | $12,547 | $(29,992) | $1,317 |
| Contract liabilities: | ||||
| Deferred revenue - Sanofi | 54,651 | 5,051 | (39,678) | 20,024 |
| Total contract liabilities | $54,651 | $5,051 | $(39,678) | $20,024 |
- Property and Equipment
Property and equipment consisted of the following as of September 30, 2024 and December 31, 2023 (in thousands):
| September 30,2024 | December 31,2023 | |
|---|---|---|
| Lab and office equipment under finance right-of-use asset | $6,824 | $6,725 |
| Lab equipment | 10,275 | 5,098 |
| Computer equipment | 966 | 582 |
| Furniture & fixtures | 3,255 | 1,064 |
| Leasehold improvements | 44,010 | 7,802 |
| Assets not yet in service | — | 37,303 |
| Total property and equipment | 65,330 | 58,574 |
| Less accumulated depreciation | (14,086) | (10,440) |
| Property and equipment, net | $51,244 | $48,134 |
Depreciation expense for the three months ended September 30, 2024 and 2023 was $2.0 million and $0.9 million, respectively. Depreciation expense for the nine months ended September 30, 2024 and 2023 was$5.4 million and $2.7 million, respectively.
Included in property and equipment is lab and office equipment right-of-use assets under finance leases with a cost basis of $6.8 million and $6.7 million and accumulated amortization expense of $3.8 million and $4.1 million as of September 30, 2024 and December 31, 2023, respectively.
Amortization expense related to right-of-use assets during the three months ended September 30, 2024 and 2023 was $0.3 million and $0.4 million, respectively. Amortization expense related to right-of-use assets during the nine months ended September 30, 2024 and 2023 was $1.1 million and $1.1 million, respectively.
- Leases
In October 2019, the Company entered into a noncancelable facility lease agreement (the “2019 Lease”) for 34,522 square feet of research and development and office space in Watertown, Massachusetts. The term of the 2019 Lease is 120 months and expires on March 31, 2030. The 2019 Lease has an option to be extended for an additional five years. The lease is not reasonably certain to be extended and as such the additional term is not included in the measurement of the lease. The 2019 Lease includes a rent escalation clause, and rent expense is being recorded on a straight-line basis. In accordance with the lease agreement, the Company is required to maintain a security deposit and provided a letter of credit to the landlord, which is recorded in restricted cash as of September 30, 2024 and December 31, 2023. The letter of credit totaled $1.3 million and $1.3 million as of September 30, 2024 and December 31, 2023, respectively.
In December 2021, the Company entered into a noncancelable lease (the “2021 Lease”) for 100,624 square feet of office and laboratory space in Watertown, Massachusetts, which the Company began occupying in February 2024. The 2021 Lease is subject to base rent of $0.8 million per month beginning two months after the commencement date, plus the Company’s ratable share of taxes, maintenance and other operating expenses. Base rent is subject to a 3% annual increase over the lease term of approximately 134 months following the commencement date. The Company also has two consecutive options to extend the term of the lease forfive years each at then-market rates. The 2021 Lease also includes a tenant improvement allowance of approximately $20.1 million. In connection with the signing of the 2021 Lease, the Company issued a letter of credit for $4.5 million which is classified as restricted cash as of September 30, 2024 and December 31, 2023.
The 2021 Lease required the landlord to build-out the base building prior to the construction of the Company’s premises. The Company concluded the accounting commencement date occurred when the landlord completed the build-out of the base building and control passed to the Company, which occurred in early January 2023. The Company assessed the classification of the 2021 Lease at the accounting commencement date and concluded the lease should be accounted for as an operating lease. The Company recorded an operating lease liability of $48.9 million, measured as the present value of the remaining lease payments discounted using the incremental borrowing rate as of the accounting commencement date. The Company recorded an operating lease right-of-use asset of $48.9 million, measured as the present value of the remaining lease payments, net of the tenant incentives.
The Company concluded the improvements paid for by the landlord in connection with the tenant improvement allowance represent lessee assets and therefore recorded $20.1 million of leasehold improvements in property and equipment. The Company recorded an additional $13.2 million of leasehold improvements in excess of the tenant improvement allowance, all of which were placed in service as of September 30, 2024.
Upon occupancy of the 2021 Lease facility in February of 2024, the Company exited the 2019 Lease facility and is actively looking to sublease the entire facility for the remaining noncancellable lease term through March 31, 2030. These actions resulted in an impairment charge of $4.9 million in thenine months ended September 30, 2024. The Company continues to evaluate the potential recovery of the ROU asset under sublease scenarios, and thus it is possible that additional impairments could be identified in future periods, and such amounts could be material.
The impairment charge reduces the carrying value of the associated ROU asset, leasehold improvements and certain furniture and fixture assets that remained in the facility to their estimated fair values. The fair values are estimated using a discounted cash flows approach based on forecasted future cash flows expected to be derived from the property based on current sublease market rent, which is considered a level 3 input in the fair value hierarchy, and other key assumptions such as future sublease market conditions and the discount rate.
The Company’s finance lease obligations consist of certain property and equipment financed through finance leases.
The components of the lease costs for thethree and nine months ended September 30, 2024 and 2023, were as follows (in thousands):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Operating lease costs | $2,493 | $2,521 | $7,484 | $7,562 |
| Finance lease costs: | ||||
| Amortization of right-to-use assets, finance leases | 314 | 369 | 1,109 | 1,108 |
| Interest expense for finance lease liabilities | 52 | 37 | 137 | 133 |
| Variable lease costs | 1,421 | 273 | 4,011 | 712 |
| Total lease costs | $4,280 | $3,200 | $12,741 | $9,515 |
Supplemental cash flow information relating to the Company’s leases for thenine months ended September 30, 2024, were as follows (in thousands):
| Nine Months EndedSeptember 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash flows used in operating leases | $6,570 | $1,989 |
| Operating cash flows used in finance leases | $1,010 | $1,001 |
| Financing cash flows used in finance leases | $137 | $133 |
Weighted average remaining lease terms and discount rates as of September 30, 2024 and 2023 were as follows:
| Nine Months EndedSeptember 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Remaining lease term: | ||
| Operating lease | 9.78 years | 10.45 years |
| Finance lease | 2.57 years | 2.13 years |
| Discount Rate: | ||
| Operating lease | 8.72% | 8.78% |
| Finance lease | 8.58% | 8.48% |
The undiscounted future lease payments for operating and finance leases as of September 30, 2024, were as follows (in thousands):
| Fiscal Year | OperatingLeases | FinanceLeases |
|---|---|---|
| 2024 (fourth quarter) | $2,954 | $354 |
| 2025 | 12,074 | 1,364 |
| 2026 | 12,436 | 1,209 |
| 2027 | 12,809 | 503 |
| 2028 | 13,193 | — |
| Thereafter | 74,424 | — |
| Total minimum lease payments | $127,890 | $3,430 |
| Less amounts representing interest or imputed interest | (42,746) | (343) |
| Present value of lease liabilities | $85,144 | $3,087 |
- Accrued Expenses
Accrued expenses consisted of the following as of September 30, 2024 and December 31, 2023 (in thousands):
| September 30,2024 | December 31,2023 | |
|---|---|---|
| Research and development expenses | $12,612 | $15,099 |
| Payroll and payroll-related | 9,530 | 11,227 |
| Professional fees | 3,353 | 3,854 |
| Other | 1,035 | 3,684 |
| Accrued expenses | $26,530 | $33,864 |
- Other Commitments and Contingencies
Legal Proceedings
In the ordinary course of business, the Company may be subject to legal proceedings, claims and litigation as the Company operates in an industry susceptible to patent legal claims. The Company accounts for estimated losses with respect to legal proceedings and claims when such losses are probable and estimable. Legal costs associated with these matters are expensed when incurred. The Company is not currently a party to any legal proceedings.
Indemnification Arrangements
As permitted under Delaware law, the Company has agreements whereby it indemnifies its investors, employees, officers, and directors (collectively, the “Indemnified Parties”) for certain events or occurrences while the Indemnified Parties are, or were serving, at its request in such capacity. The term of the indemnification period is for the Indemnified Parties’ lifetime. The Company believes the estimated fair value of these indemnification agreements is minimal. The Company enters into standard indemnification agreements in the ordinary course of business. Pursuant to these agreements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified party for losses suffered or incurred by the indemnified party, generally the Company’s business partners or customers, in connection with any U.S. patent or any copyright or other intellectual property infringement claim by any third party with respect to the Company’s products. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. The Company is not aware of any claims under indemnification arrangements, and it hasnot accrued any liabilities related to such obligations as of September 30, 2024 or December 31, 2023.
- Equity-Based Compensation
2018 Stock Option and Grant Plan
In November 2018, the Company adopted, and its stockholders approved, the 2018 Stock Option and Grant Plan (the “2018 Plan”), which provides for the granting of stock options and other equity-based awards at the discretion of the Board of Directors or any subcommittee of the Board of Directors to the Company’s employees, officers, directors, and independent contractors. No further grants will be made under the 2018 Plan. However, the 2018 Plan will continue to govern outstanding equity awards granted thereunder. To the extent outstanding options granted under the 2018 Plan are cancelled, forfeited or otherwise terminated without being exercised and would otherwise have been returned to the share reserve under the 2018 Plan, the number of shares underlying such awards will be available for future grant under the 2020 Stock Option and Incentive Plan.
2020 Stock Option and Incentive Plan
In August 2020, the Company and its stockholders approved the 2020 Stock Option and Incentive Plan (the “2020 Plan”), which became effective on August 20, 2020. The 2020 Plan replaced the 2018 Plan as the Company’s Board of Directors has determined not to make additional awards under the 2018 Plan following the closing of the Company’s IPO. The 2020 Plan allows the Company to make equity-based and cash-based incentive awards to its officers, employees, directors and consultants. The Company has initially reserved 4,457,370 shares of its common stock for the issuance of awards under the 2020 Plan, which includes the shares of common stock remaining available for issuance under its 2018 Plan as of the business day immediately prior to the effective date of the registration statement. The 2020 Plan provides that the number of shares reserved and available for issuance will automatically increase on January 1, 2021 and each January 1 thereafter, by 4% of the Company’s outstanding number of shares of common stock on the immediately preceding December 31, or such lesser number of shares as determined by the Company’s compensation committee. These limits are subject to adjustment in the event of a stock split, stock dividend or other change in the Company’s capitalization. In June 2024, in connection with the Company's 2024 annual shareholder meeting, shareholders approved an amendment to the 2020 stock option plan that redefined the definition of common stock outstanding for the purposes of calculating the annual increase to the shares available for issuance. After the amendment, outstanding equity includes all outstanding common shares as well as outstanding pre-funded warrants. As of September 30, 2024, there were an aggregate of 3,455,849 shares remaining available for future grants.
2020 Employee Stock Purchase Plan
In August 2020, the Company and its stockholders approved the 2020 Employee Stock Purchase Plan (the “2020 ESPP”), which became effective August 20, 2020. The 2020 ESPP initially reserved and authorized the issuance of up to a total of 445,653 shares of common stock to participating employees. The 2020 ESPP provides that the number of shares reserved and available for issuance will automatically increase on January 1, 2021 and each January 1 thereafter through January 1, 2030, by the lesser of (i)438,898 shares of common stock, (ii)1% of the Company’s outstanding number of shares of common stock on the immediately preceding December 31 or (iii) such lesser number of shares of common stock as determined by the administrator of the 2020 ESPP. The number of shares reserved under the 2020 ESPP is subject to adjustment in the event of a stock split, stock dividend or other change in the Company’s capitalization. As of September 30, 2024, there were an aggregate 1,957,168 shares remaining available for future grants.
Stock Options
A summary of stock option activity under the 2020 Plan during thenine months ended September 30, 2024 is as follows (in thousands except share and per share data):
| Number ofOptionsOutstanding | WeightedAverageStrikePrice perOption | WeightedAverageRemainingContractualTerm(in years) | AggregateIntrinsicValue | |
|---|---|---|---|---|
| Outstanding at December 31, 2023 | 8,113,164 | $28.25 | 7.69 | $49,622 |
| Granted | 2,473,796 | 42.14 | ||
| Exercised | (695,821) | 13.82 | ||
| Forfeited | (267,571) | 36.04 | ||
| Outstanding at September 30, 2024 | 9,623,568 | $32.68 | 7.62 | $149,181 |
| Exercisable at September 30, 2024 | 5,842,808 | $29.50 | 6.79 | $110,889 |
The intrinsic value of stock options exercised during the three months ended September 30, 2024 and 2023 was $10.4 million and $1.1 million, respectively. The intrinsic value of stock options exercised during thenine months ended September 30, 2024 and 2023 was $19.0 million and $7.9 million, respectively.
The weighted-average fair value of options granted during the three months ended September 30, 2024 and 2023 was $29.36 and $13.35, respectively. The weighted-average fair value of options granted during thenine months ended September 30, 2024 and 2023 was $26.03 and $18.19 respectively.
As of September 30, 2024, the total unrecognized stock-based compensation expense for unvested stock options was $80.7 million, with a weighted average recognition period of 2.1 years.
The following table outlines our equity-based compensation expense for stock options for thethree and nine months ended September 30, 2024 and 2023:
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Research and development | $5,950 | $4,931 | $16,925 | $14,091 |
| General and administrative | 6,432 | 5,440 | 18,060 | 14,899 |
| Total equity-based compensation | $12,382 | $10,371 | $34,985 | $28,990 |
The weighted-average assumptions that the Company used in the Black-Scholes option pricing model to determine the grant date fair value of stock options granted to employees and non-employees for thethree and nine months ended September 30, 2024 and 2023 were as follows:
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Expected term (in years) | 6.08 | 6.08 | 5.79 | 5.86 |
| Volatility | 67% | 62% | 65% | 62% |
| Risk-free interest rate | 3.69% | 4.14% | 4.12% | 4.06% |
| Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Restricted Stock Units
The Company has granted shares of restricted stock units with service-based and performance-based vesting conditions. A summary of restricted stock activity during thenine months ended September 30, 2024 is as follows:
| Number ofUnitsOutstanding | Grant DateFair Valueper Share | |
|---|---|---|
| Unvested at December 31, 2023 | 593,140 | $25.36 |
| Granted | 396,272 | 38.68 |
| Vested | (168,731) | 25.25 |
| Forfeited | (37,386) | 27.38 |
| Unvested at September 30, 2024 | 783,295 | $32.03 |
During the three months ended September 30, 2024 and 2023, the Company granted 152,288 and 129,570 restricted stock units, respectively. During thenine months ended September 30, 2024 and 2023, the Company granted 396,272 and 393,556 restricted stock units, respectively. As of September 30, 2024, the total unrecognized stock-based compensation expense for unvested restricted stock was $19.9 million with a weighted average recognition period of 2.3 years.
During the three months ended September 30, 2024 the Company recognized approximately $2.3 million of expense for restricted stock of which $1.5 million and $0.8 million was recorded in research and development and general and administrative expense, respectively. During thenine months ended September 30, 2024 the Company recognized approximately $5.6 million of expense for restricted stock of which $3.6 million and $2.0 million was recorded in research and development and general and administrative expense, respectively. During thethree months ended September 30, 2023 the Company recognized approximately $1.1 million of expense for restricted stock of which $0.7 million and $0.4 million was recorded in research and development and general and administrative expense, respectively. During thenine months ended September 30, 2023 the Company recognized approximately $2.6 million of expense for restricted stock of which $1.7 million and $0.9 million was recorded in research and development and general and administrative expense, respectively.
Equity-Based Compensation Expense
Total equity-based compensation expense recorded as research and development and general and administrative expenses for employees, directors, and non-employees during thethree and nine months ended September 30, 2024 and 2023 is as follows (in thousands):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Research and development | $7,604 | $5,795 | $20,944 | $16,227 |
| General and administrative | 7,300 | 5,860 | 20,269 | 15,993 |
| Total equity-based compensation | $14,904 | $11,655 | $41,213 | $32,220 |
- Related-Party Transactions
Other than the collaborations discussed in Note 5, the Company had no related party transactions for the periods presented in the accompanying condensed consolidated financial statements, which have not otherwise been discussed in these notes to the condensed consolidated financial statements.
- Income Taxes
Income taxes for the three and nine months ended September 30, 2024 and 2023 have been calculated based on an estimated annual effective tax rate and certain discrete items. The company recorded immaterial income tax expense related to investment income for the three and nine months ended September 30, 2024 and 2023.
The Company has never been examined by the Internal Revenue Service or any other jurisdiction for any tax years and, as such, all years within the applicable statutes of limitations are potentially subject to audit.
- Net Loss per Share
Net Loss per Share
Basic and diluted loss per share is computed by dividing net loss by the weighted-average common shares outstanding for the period, including the pre-funded warrants given their nominal exercise price (in thousands, except for share and per share data):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Numerator: | ||||
| Net loss | $(62,487) | $(52,867) | $(153,106) | $(132,594) |
| Denominator: | ||||
| Weighted average common shares outstanding, basic and diluted | 76,125,975 | 58,421,859 | 73,330,338 | 58,312,813 |
| Net loss per share, basic and diluted | $(0.82) | $(0.90) | $(2.09) | $(2.27) |
The Company’s potentially dilutive securities, which include restricted stock and stock options, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following from the computation of diluted net loss per share attributable to common stockholders at September 30, 2024 and 2023 because including them would have had an anti-dilutive effect:
| Nine Months EndedSeptember 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Unvested restricted stock | 783,295 | 587,667 |
| Options to purchase common stock | 9,623,568 | 8,249,939 |
| Total | 10,406,863 | 8,837,606 |
- Subsequent Events
On October 30, 2024, Cowen acknowledged and accepted our prior written notice to terminate the Cowen Sales Agreement, which termination was effective on October 30, 2024. As a result of such termination, we will not offer or sell any additional shares of common stock under the Cowen Sales Agreement.
On October 31, 2024, we entered into an Open Market Sale Agreement SM, or Jefferies Sales Agreement, with Jefferies LLC, or Jefferies, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $300.0 million from time to time in “at-the-market” offerings through Jefferies, as our sales agent. We agreed to pay Jefferies a commission of up to 3.0% of the gross proceeds of any shares sold by Jefferies under the Sales Agreement. As of the date of this Quarterly Report on Form 10-Q, we have not sold any shares of common stock under the Jefferies Sales Agreement.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.